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OpenTrials
Completed

NCT Number: NCT02867735

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema

To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)

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Key information

Conditions

Macular Edema Cardiovascular Diseases Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Macular Degeneration Neovascular Age-related Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Retinal Vein Occlusions Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Arecibo, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO

The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)

Vital signs as specified within the protocol

Exclusion criteria

-Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage

Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening

other ocular conditions as specified in the protocol

systemic conditions as specified in the protocol

Treatment and study plan

LKA651

Drug

Interventional

Sham Comparator

Other

Primary outcomes

  1. Number Of participants with Adverse Events as a measure of Safety and Tolerability

    Time frame: Day 1 through study completion

    To evaluate the safety and tolerability of LKA651 by reviewing any adverse events after medical or ophthalmic examinations that are possibly or probably related to study drug.

Secondary outcomes

  1. Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)

    Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85

    To evaluate the serum pharmacokinetic profile of LKA651 Measured by AUC(0-last) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-time point.

  2. Pharmacokinetics of Single Dose of LKA651 - Cmax

    Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85

    To evaluate the serum pharmacokinetic profile of LKA651 Measured by Cmax - The maximum plasma concentration of study medication.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2016
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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